Internal Market, Industry, Entrepreneurship and SMEs

Library

Library

The Library is your entry point to a comprehensive database of documents produced by stakeholders throughout the European Union related to medical devices and in-vitro medical devices, in addition to and to all relevant websites. The Library also includes all key resources produced by DG GROW related to the Regulations on medical devices and in-vitro medical devices.

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You can use the tool below to filter through our database of external resources by year, country, language and area of interest to find the documents you require.

Showing results : 71 - 80 of 83
Areas of interests : Manufacturers MD, Manufacturers IVD, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : May 05 2017 | Country : United Kingdom | Language : English

This BSI Group presentation deals with the difference between a Directive and a Regulation and provides information on what will change under the new IVDR.

Areas of interests : Manufacturers MD, Manufacturers IVD, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : May 05 2017 | Country : United Kingdom | Language : English

This BSI Group presentation deals with the difference between a Directive and a Regulation and provides information on what will change under the new MDR.

Areas of interests : Manufacturers MD, Manufacturers IVD, The procurement of MDs and IVDs, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : May 05 2017 | Country : Ireland | Language : English

The purpose of this document is to provide guidance to industry in the area of distribution of medical devices, in vitro medical devices and their accessories for human use in Ireland.

Areas of interests : Manufacturers MD, Manufacturers IVD, The procurement of MDs and IVDs, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : May 05 2017 | Country : Ireland | Language : English

This information pack from the Irish Health Products Regulatory Authority provides advice on the practical application of the new EU device Regulations.

Areas of interests : Manufacturers MD, Manufacturers IVD, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : May 02 2017 | Country : United Kingdom | Language : English

This document aims to answer some key questions on the new IVDR and the changes that it brings for the IVD industry. Questions are grouped by key theme.

Areas of interests : Manufacturers MD, Manufacturers IVD, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : May 01 2017 | Country : Taiwan | Language : Chinese

This information sheet from BSI Group provides information on webinars, white papers and FAQs related to the transition to the MDR and IVDR.

Areas of interests : Manufacturers MD, Manufacturers IVD, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Apr 04 2017 | Country : European Union | Language : English

This press release from MedTech Europe announces the adoption by the EU Parliament of the new diagnostics and medical device regulations and discusses a focus shift to implementation.

Areas of interests : Manufacturers MD, Manufacturers IVD, The procurement of MDs and IVDs, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Mar 09 2017 | Country : European Union | Language : English

This presentation from a Commission/CAMD stakeholder meeting on the revision of the EU medical devices legislation presents the main features of the new texts and some key aspects towards implementation.

Areas of interests : Manufacturers MD, Manufacturers IVD, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Mar 01 2017 | Country : United Kingdom | Language : English

This BSI Group presentation covers roles and responsibilities in the MDR and IVDR regulatory system.

Areas of interests : Manufacturers MD, Manufacturers IVD, The procurement of MDs and IVDs, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Mar 01 2017 | Country : Ireland | Language : English

This Irish Health Products Regulatory Authority newsletter from March 2017 covers the fact that the new Regulations on medical devices and in-vitro diagnostic medical devices were agreed at European level.

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